NCT06611007招募中1 期
Evaluation of the Safety of LipiodolⓇ Embolization in Symptomatic Digital Osteoarthritis Refractory to Conventional Treatment: a Pilot Study of 15 Patients
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年1月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety of arterial embolization using Lipiodol® in patients with symptomatic hand osteoarthritis refractory to conventional treatment. It will also learn about the efficacy of arterial embolization with Lipiodol® in reducing pain and improving hand function.
The main questions it aims to answer are:
- What are the side effects and complications associated with the Lipiodol® arterial embolization procedure?
- Does arterial embolization reduce pain intensity and improve hand function?
Researchers will evaluate patients over a 6-month period to assess the safety of Lipiodol® embolization and its impact on joint pain, swelling, and functional capacity. Participants will:
- Undergo arterial embolization with Lipiodol®
- Participate in regular follow-ups to monitor pain relief, hand function, and any side effects
- Have imaging studies to assess changes in joint vascularisation and damage
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 40 years.
- •Osteoarthritis of the hand according to American College of Rheumatology criteria 1990
- •Osteoarthritis affecting at least two proximal and/or distal interphalangeal joints with a radiological Kellgren-Lawrence stage ≥
- •Symptomatic osteoarthritis within the last 3 months.
- •Visual analogue pain scale of the hand to be treated ≥ 40/100 mm (most painful hand).
- •Inadequate response, adverse effects and/or contraindication to NSAIDs and non-opioid analgesics.
- •Patient affiliated to french social security or a similar health assurance.
排除标准
- •History of allergy to iodinated contrast media, LipiodolⓇ or poppies.
- •Vasomotor disorders (Raynaud's syndrome, scleroderma, acrocyanosis).
- •Stenosis (>50%) or known atheromatous arterial occlusion of the upper limbs.
- •Obliterative arterial disease of the lower limbs at the critical ischaemia stage.
- •Severe to end-stage chronic renal insufficiency (glomerular filtration rate < 30ml/min/1.73m2), dialysis or renal transplant.
- •Arteritis such as thromboangiitis obliterans disease or other diseases
- •Previous thrombosis/dissection of the radial artery.
- •Chronic inflammatory rheumatic disease (rheumatoid arthritis, psoriatic arthritis, microcrystalline arthritis, etc.).
- •Known hyperthyroidism or large multinodular goiter.
- •Traumatic lesions, haemorrhages or chronic bleeding in the hand (not completely resolved within 3 months of the start of the lesion) requiring embolisation.
- •Pregnant or breast-feeding.
- •Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code and/or who do not speak French.
- •Patients in a period of exclusion or in the course of another interventional clinical trial.
研究组 & 干预措施
Arterial embolization of the hand with Lipiodol
Experimental
The radial artery will be embolized with Lipiodol emulsified 3:1 with iodinated contrast medium (Optiray 300 mg/ml). The most painful hand according to VAS pain will be treated.
干预措施: embolization therapy (Drug)
结局指标
主要结局
Number and Frequency of Embolisation-Related Adverse Events as Assessed by CTCAE
时间窗: From embolization to 6 months after embolization
The primary endpoint is the number and frequency of embolisation-related adverse events throughout the study period (6 months). Each adverse event will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) from grade 1 (mild) to grade 5 (fatal).
次要结局
- Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 1(baseline and month 1)
- Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 3(Baseline and Month 3)
- Change Percentage of Participants Achieving at least a 50% improvement of pain Analog Visual Scale score at month 6(Baseline and Month 6)
- Change From Baseline in Swollen Joints Counts at Month 1(Baseline and Month 1)
- Change From Baseline in Swollen Joints Counts at Month 3(Baseline and Month 3)
- Change From Baseline in Swollen Joints Counts at Month 6(Baseline and Month 6)
- Change From Baseline in Tender Joints Counts at Month 1(Baseline and Month 1)
- Change From Baseline in Tender Joints Counts at Month 3(Baseline and Month 3)
- Change From Baseline in Tender Joints Counts at Month 6(Baseline and Month 6)
- Change From Baseline in Cochin Hand Function Index score at Month 1(From Baseline and Month 1)
- Change From Baseline in Cochin Hand Function Index score at Month 3(From Baseline and Month 3)
- Change From Baseline in Cochin Hand Function Index score at Month 6(From Baseline and Month 6)
- Change From Baseline in Functional Index for Hand Osteoarthritis at Month 1(From Baseline and Month 1)
- Change From Baseline in Functional Index for Hand Osteoarthritis at Month 3(From Baseline and Month 3)
- Change From Baseline in Functional Index for Hand Osteoarthritis at Month 6(From Baseline and Month 6)
- Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 1(From Baseline and Month 1)
- Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 3(From Baseline and Month 3)
- Change From Baseline in quick Disabilities of the Arm, Shoulder, and Hand at Month 6(From Baseline and Month 6)
- Change from Baseline in Hand grip strength at Month 1(Baseline and Month 1)
- Change from Baseline in Hand grip strength at Month 3(Baseline and Month 3)
- Change from Baseline in Hand grip strength at Month 6(Baseline and Month 6)
- Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 1(Baseline and Month 1)
- Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 3(Baseline and Month 3)
- Change from Baseline of Number and Severity of joint vascularization assessed by doppler Ultrasound at Month 6(Baseline and Month 6)
- Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 1(Baseline and Month 1)
- Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 3(Baseline and Month 3)
- Change from Baseline of Number and Severity of synovitis assessed by Ultrasound at Month 6(Baseline and Month 6)
- Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 1(Baseline and Month 1)
- Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 3(Baseline and Month 3)
- Change from Baseline of Number and Severity of joint effusion assessed by Ultrasound at Month 6(Baseline and Month 6)
- Change from 6 months prior to inclusion in use of pain medication over the 6 months of study(From 6 months before inclusion to Month 6)
- Change in the intensity of neovascularisation in the hand joints, as assessed by arteriography, from before embolisation to immediately after embolisation(Before and Immediately after embolisation)
- Change From Baseline in Ghent University Scoring System (GUSS) at Month 6(Baseline and Month 6)
- Change in hand cutaneous microcirculation assessed by Laser Speckle Contrast Imaging (LSCI) before and during two hours post embolization(Before embolisation and 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes post embolisation)
研究者
研究点 (2)
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